Papers and Presentations
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In-depth Characterization of Cell Therapy Products Using Mass Spectrometry-based Proteomics
Speaker Presentation Wang Lei, Takeda, 2021
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Evaluation of Host Cell Proteins in Lenti Viral Vectors
Speaker Presentation Suravajhala Shilpa, bluebird bio, Inc., 2021
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The Integration of Mass Spectrometry to the Process Development of Fusion Protein Therapeutics
Speaker Presentation Shao Chun, Bristol-Myers Squibb Company, 2021
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Strategic Developing Process Analytical Technologies for Real Time Quality Attribute Analysis in Bioprocess Development
Speaker Presentation Ding Julia, Bristol-Myers Squibb Company, 2021
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Registration of Alternate Filters During Raw Material Shortages
Speaker Presentation Rhee Amy, Amgen Inc., 2021
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One Resin, Multiple Products: A Potential Solution for Supply Constraints
Speaker Presentation Mahajan Ekta, Genentech, a Member of the Roche Group, 2021
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Forced Degradation and MAM Workflows in Lead Optimization/Early Development
Speaker Presentation George Thompson, Alayna AbbVie Inc., 2021
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Application of MAM during Drug Development: Overcoming Technical Challenges While Advancing Product and Process Knowledge
Speaker Presentation Powers Thomas, Pfizer, Inc., 2021
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'Reliance' on Inspections: Not Just a Buzzword but a Real Opportunity
Speaker Presentation Raviol Holger, F. Hoffmann La Roche Ltd., 2021
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Accelerated Technology Transfer to Meet Demand for a Repurposed Biologic: Challenges, Successes and Lessons Learned
Speaker Presentation Raviol Holger, F. Hoffmann La Roche Ltd., 2021
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Regulatory Issues in the Context of Health Emergencies - Learnings and Recommendations
Speaker Presentation Lumsden Rebecca, Pfizer Limited, 2021
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Expedited Product Development: Application of Regulatory Lessons Learned
Speaker Presentation Levis Robin, CBER, FDA, 2021
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RBD-specific Polyclonal F(ab')2 Fragments of Equine Antibodies Improve Survival in Severe Patients Hospitalized with COVID-19
Speaker Presentation Goldbaum Fernando, Inmunova S.A., 2021
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Pandemic Preparedness: Regulatory Agility in the Era of COVID-19 - Latin America
Speaker Presentation Fernandes Jason, Health Canada, 2021
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Regulatory Perspectives on the Accelerated Development of Bamlanivimab - a SARS-CoV-2 Neutralizing Antibody
Speaker Presentation Dobbins JR, Eli Lilly and Company, 2021
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Reliance, Virtual Inspections and Regulations - Brazilian Strategies During COVID-19 Pandemic
Speaker Presentation Ihatanderson Alves da Silva, ANVISA-National Health Surveillance Agency, 2021
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Extraterrestrial Mass Spectrometry: Searching for Habitable Environments in the Solar System
Speaker Presentation Trainer Melissa, NASA, 2021
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The Integration of Mass Spectrometry to the Process Development of Fusion Protein Therapeutics
Speaker Presentation Shao Chun, Bristol-Myers Squibb Company, 2021
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Characterization of Modifications on Bispecific Protein Using Native Ion Exchange Chromatography Coupled to Mass Spectrometry
Speaker Presentation Shah Arnik, Amgen Inc., 2021
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Scientific and Regulatory Perspectives on Mass Spectrometry-based Strategies During Early Stages of Therapeutic Development for COVID-19
Speaker Presentation Rao Ashutosh, CDER, FDA, 2021